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Neurotech Pharmaceuticals has released an update regarding its biologics license application (BLA) for NT-501 (revakinagene taroretcel), a treatment designed for macular telangiectasia type 2 (MacTel). The U.S. Food and Drug Administration (FDA) has recently extended the Prescription Drug User Fee…

The U.S. FDA has granted fast track designation to FLQ-101, FELIQS’ oral and intravenous solution targeting retinopathy of prematurity (ROP). This designation will accelerate the regulatory review process for FLQ-101, a promising treatment for a condition currently lacking approved preventative…

Clearside Biomedical has announced that Arctic Vision, its Asia-Pacific partner, has signed a commercial collaboration agreement with Santen Pharmaceutical Co. for ARVN001 (known in the United States as XIPERE) to treat uveitic macular edema (UME) and additional ophthalmic indications in…

The U.S. FDA has granted LumiThera authorization to market its Valeda Light Delivery System, the first FDA-authorized device designed to treat vision loss in patients with dry age-related macular degeneration (AMD). This significant approval, obtained through the De Novo authorization…

Genentech recently announced encouraging one-year results from its phase 4 ELEVATUM study evaluating Vabysmo (faricimab-svoa) for diabetic macular edema (DME) in racially and ethnically underrepresented populations. The findings, presented at the American Academy of Ophthalmology (AAO) 2024 annual meeting in…

The U.S. FDA has granted investigational drug clearance for HG202, a pioneering CRISPR/Cas13Y RNA-editing therapy developed by HuidaGene to treat neovascular (wet) age-related macular degeneration (AMD). This milestone makes HG202 the first CRISPR/Cas13Y RNA-targeting therapy in clinical development and the…

BlueRock Therapeutics, a subsidiary of Bayer, announced that the FDA has cleared its investigational new drug (IND) application for OpCT-001, a stem cell therapy designed to treat primary photoreceptor diseases. The clearance allows BlueRock to initiate a phase 1/2a clinical…

A recent study highlights the potential of ChatGPT-4o in accurately answering questions related to retinal diseases, covering diagnostic criteria, treatment guidelines, and management strategies. The AI’s performance was evaluated by vitreoretinal specialists, focusing on its alignment with the American Academy of…

Atsena Therapeutics announced that 12-month safety and efficacy data from its Phase I/II trial of ATSN-101, a gene therapy for Leber congenital amaurosis caused by GUCY2D mutations (LCA1), were published in The Lancet. ATSN-101 showed durable improvements in vision at…

Dr. Christopher Cioffi, the Thomas and Constance D’Ambra Professor in Organic Chemistry at Rensselaer Polytechnic Institute, is collaborating with Dr. Konstantin Petrukhin, Professor of Ophthalmic Science at Columbia University, to develop promising compounds aimed at treating dry age-related macular degeneration…